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临床试验/NCT07759024
NCT07759024尚未招募不适用

Maternal and Fetal Prognosis of Cesarean Delivery in Critically Ill Patients

Société Française d'Anesthésie et de Réanimation0 个研究点目标入组 200 人开始时间: 2026年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
200
主要终点
Maternal mortality

研究概览

简要总结

Cesarean delivery in critically ill pregnant women, especially outside the operating room, is a rare but high-risk situation for both mother and fetus. These patients often suffer from severe conditions (hypertensive disorders, hemorrhage, respiratory failure, infection, or trauma) and may require emergency cesarean in the ICU, emergency department, or prehospital setting.

They frequently need advanced organ support and face higher rates of complications, prolonged ICU stay, and maternal mortality. Non-OR environments also create challenges in sterility, coordination, and management. Neonatal outcomes are often impaired by iatrogenic prematurity.

Current evidence is limited. A large nationwide registry is needed to better describe outcomes and support future protocols and recommendations.

详细描述

Cesarean delivery performed in critically ill pregnant women, particularly outside the operating room (OR), represents a rare but extremely high-risk clinical situation for both mother and fetus. These patients are admitted to intensive care units (ICUs) because of severe maternal conditions such as hypertensive disorders of pregnancy, hemorrhagic shock, acute respiratory failure, severe infections, or major trauma. Although these conditions have been extensively described in the critical care obstetric literature, data specifically addressing cesarean delivery performed outside the operating room remain scarce.

In life-threatening situations, emergency cesarean delivery may be required to preserve maternal and/or fetal life and may be performed directly in the ICU, high-dependency unit, emergency department, or even in the prehospital setting. Such situations have mainly been described in maternal cardiac arrest, perimortem cesarean delivery, severe trauma, and catastrophic maternal deterioration.

Women requiring cesarean delivery outside the operating room frequently present with multiple organ failure requiring advanced organ support, including prolonged mechanical ventilation, vasopressor therapy, renal replacement therapy, or extracorporeal membrane oxygenation (ECMO). These critically ill obstetric patients experience higher rates of hemorrhagic complications, nosocomial infections, prolonged ICU stay, and maternal mortality than women delivering in conventional obstetric settings.

Furthermore, non-operating room environments are not specifically designed for obstetric surgery, creating additional challenges regarding sterility, multidisciplinary coordination, hemodynamic management, anesthesia, and thromboembolic prevention.

Neonatal outcomes are also of major concern. Emergency fetal extraction frequently results in iatrogenic prematurity, increasing the risk of respiratory distress syndrome, perinatal asphyxia, severe neonatal infection, and prolonged admission to the neonatal intensive care unit (NICU). Neonatal prognosis mainly depends on gestational age at delivery and maternal hemodynamic stability.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •Women aged ≥18 years.
  • •Pregnancy ≥22 weeks of gestation.
  • •Admission (or planned admission) to a critical care unit.

排除标准

  • •Age <18 years.
  • •Objection to the use of medical data.
  • •Patients under legal protection (guardianship or similar legal measures).

研究组 & 干预措施

Study group:

• Study group: cesarean delivery performed outside the operating room (ICU, high-dependency unit, emergency department, or prehospital setting).

Comparison group

• Comparison group: women admitted to critical care without cesarean delivery outside the operating room, including:

  • cesarean delivery performed in the operating room;
  • women who did not undergo cesarean delivery.

Descriptive subgroup:

• Descriptive subgroup: women who died during pregnancy (≥22 weeks of gestation) without undergoing cesarean delivery.

结局指标

主要结局

Maternal mortality

时间窗: during pregnancy or within 42 days after the end of pregnancy

Maternal mortality, defined according to the ICD-10 classification as any death occurring during pregnancy or within 42 days after the end of pregnancy from any cause related to or aggravated by the pregnancy or its management, excluding accidental or incidental causes. The end of pregnancy will be defined as the date of cesarean delivery or vaginal delivery. Women dying before delivery will be considered as maternal deaths occurring during pregnancy.

次要结局

  • Incidence(up to delivery)
  • Description of the organisational arrangements for performing caesarean sections outside the operating room(up to delivery)
  • •Maternal adverse outcomes (observed or not)(peri and post delivery)
  • Neonatal mortality(Day 28)
  • Neonatal adverse outcomes(during hospitalization)
  • cesarean delivery and maternal comorbidities(Baseline, before delivery)

研究者

发起方
Société Française d'Anesthésie et de Réanimation
申办方类型
Other
责任方
Sponsor

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